A Comparison of the Paediatric i-gel™ and the Pro-seal LMA™. (V-9/10)

• Research type

  Research Study

• Full title

  A Comparison between the i-gel™ and LMA Pro-Seal™ Supraglottic Airway Devices in Children

• IRAS ID

  47492

• Sponsor organisation

  Cardiff And Vale University Health Board

• Eudract number

  0000000000000

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  During anaesthesia for surgery it is necessary to support the child's breathing. Commonly this is done by inserting a laryngeal mask airway (LMA) into the back of the child's throat once they are asleep. This allows oxygen and anaesthetic vapours to be administered and the breathing monitored. We aim to compare the current gold standard LMA (LMA Pro-Seal?½) with the paediatric i-gel?½ which has recently been launched in the market. The 2 devices have been compared in adult patients, but since the paediatric i-gel?½ has only recently been introduced (10 months into mainstream use) no work has been done in children. The i-gel?½ has been shown to be as effective, and with a few added benefits, as the LMA Pro-Seal?½ in the adult population. Therefore we want to compare the 2 LMAs (both size 2 LMAs) in children aged between 2 and 6 years, and weighing between 10 and 20 kgs. We plan to do a randomised, non-crossover study recruiting 50 patients in each group. The primary objective would be to identify a difference in effective insertion of the devices in the first attempt, with secondary objectives being ease of insertion, time to successful insertion, how well it sits in the airway (measured using a fiberoptic scope), ease of passing a gastric tube down its port and to identify any trauma to the airway. The study will take place in the University Hospital of Wales in Cardiff and is expected to last about 6 months.

• REC name

  Wales REC 3

• REC reference

  10/MRE09/39

• Date of REC Opinion

  4 May 2011

• REC opinion

  Further Information Favourable Opinion